A Phase 1 interventional study of Talimogene Laherparepvec (T-VEC) in Non-melanoma Skin Cancer, Basal Cell Carcinoma and Squamous Cell Carcinoma, sponsored by University of Zurich. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-18.
Sponsored by University of Zurich · Phase 1, Interventional, and Treatment
Evaluation of the mechanism of Action of talimogene laherparepvec (T-VEC) in patients with locally advanced non-melanoma skin cancer.
This study evaluates the administration of T-VEC in non-melanoma skin cancer. The aim is to evaluate the effectiveness, safety and tolerability of T-VEC in patients with non-melanoma skin cancer through determination of local immune effects after repeated T-VEC injections.
Exclusion Criteria:
Intralesional injections of T-VEC up to 4.0 mL of 10 to the 6 plaque-forming Units/mL (PFU/mL)
Genetic: Talimogene Laherparepvec (T-VEC)
a modified herpes simplex virus-1 (HSV-1) containing the gene coding for human granulocyte macrophage colony-stimulating factor (GM-CSF)
Change from Baseline local immune effects after repeated T-VEC injections
Detection of increased local immune activation markers in skin biopsies of injected lesions. The following markers will be assessed by Polymerase chain reaction (PCR): interferon (IFN), 2-prime, 5-prime oligoadenylate synthetase 1 (OAS1), Interferon-induced GTP-binding protein MxA (MXA) and C-X-C motif chemokine 11 (CXCL11)
Time frame: at baseline, after 3 injections (week 6) and optionally after 6 injections (week 12)
Detection of Tumor Regression using World Health Organization (WHO) response criteria
Measurement of the treated tumor size will be performed at baseline and at each visit until end of the study
Time frame: at baseline and at week 22
Systemic immune response
Detection of increased systemic immune Response markers in sera and peripheral blood mononuclear cells by multi-Color fluorescence-activated cell sorting (FACS)
Time frame: at baseline and week 6, optionally also at week 12
Analysis of Adverse events
All serious and non-serious adverse events that occur after enrollment through 30 (+7) days after the last administration of T-VEC will be recorded
Time frame: At week 1, 4, 6, 8, 10, 12, 14, 16, 18, 22
Plan to share: No
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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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University of Zurich